Sponsor Name

ROBOCATH

Brief summary

• The R-OneTM robotic platform is currently indicated for remote delivery and manipulation of coronary guidewires and stent/balloon devices during percutaneous coronary interventions. Robocath is seeking to expand the indication for use to include the common carotid artery, commonly classified as part of the peripheral vasculature. The objective of the study is to assess the feasibility of the R-One ^TM device in carotid artery stenting.

Primary endpoints

• Procedure technical success, absence of any unplanned manual assistance or conversion to manual CAS for procedural completion

CERC Services

• Study coordination
• Regulatory submissions
• Site contract management
• EDC management
• Data management
• Statistical analysis

Countries

France

Number of investigational sites: 01